SERM Medical Director

Il y a 17 heures

SintKatelijneWaver, Vlaanderen, Belgique GSK Temps plein
Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Find out more: Our approach to R&D

Position Summary

Provides medical and scientific leadership in the safety evaluation and risk management of GSK’s oncology assets in clinical development.

Responsible for the interpretation of safety data, identification and escalation of safety signals, and delivery of clear, evidence-based recommendations to support benefit–risk decisions. This role contributes to global governance and plays a critical part in protecting patient safety and shaping the safety profile of innovative oncology medicines.

Key Responsibilities

Scientific / Medical & Pharmacovigilance Expertise

Lead pharmacovigilance and risk management activities for assigned oncology assets and clinical trials

Define and drive strategy for the evaluation and management of safety issues across the clinical development lifecycle

Analyseand interpret clinical data, literature, and emerging evidence toidentifyand assess safety signals

Provide expert medical input into the safety components of global regulatory submissions

Apply sound clinical judgement to complex and sometimes conflicting data sets to inform benefit–risk decisions

Ensuretimelyescalation of safety concerns in line with governance processes

Matrix Leadership & Cross-functional Collaboration

Represent Safety on cross-functional Clinical Matrix and Project Teams

Lead cross-functional teams to address urgent and complex product safety issues

Actively contribute to and, whereappropriate, lead Safety Review Teams (SRTs)

Build strong, collaborative relationships across functions and geographies

Coach and mentor colleagues, contributing to capability development within theorganisation

Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders

Communication, Influence & Governance

Lead presentations on safety issues and recommendations to senior governance committees

Influence decision-making through clear, credible, and evidence-based communication

Represent GSK in interactions with regulatory authorities, external experts, and partners

Contribute to the development of safety strategy for clinicalprogrammesand broader SERM activities

Identifyopportunities to improve processes, drive innovation, and enhance operational effectiveness

Operate with strong awareness of the internal and external regulatory and scientific environment

Why Join Us? This is an opportunity to play a pivotal role in advancing GSK’s oncology pipeline, withdirectimpact on patient safety and global health outcomes.

You will:

Shape the safety strategy of innovative oncology medicines

Engage with senior governance and influence key development decisions

Work within a highly collaborative, global matrix environment

Contribute to scientific excellence and continuous improvement in safety science

Basic Qualifications

Medical degree with current GMC registration (or eligibility topractisein the UK) and relevant clinical experience

Completion of formal postgraduate clinical training (e.g., residency or specialty training)

Significant experiencein pharmacovigilance, drug safety, or medical affairs

Demonstratedexpertisein signal detection, evaluation, and risk management

Strong understanding of clinical development and post-marketing safety processes

Experience working effectively in matrixed, cross-functional environments

Excellent written and verbal communication skills, including preparation of medical and regulatory documents

Strong clinical judgement and the ability to deliver clear, evidence-based recommendations

Preferred Qualifications

Postgraduatespecialisationin a clinical discipline or pharmaceutical medicine

Experience contributing to regulatory submissions and periodic safety reports

Knowledge of epidemiology, biostatistics, or real-world evidence relevant to safety assessment

Experience leading Safety Review Teams or acting as safety lead for majorprogrammes

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